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3474
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9859
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8525
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5948
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1956
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5146
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8136
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6605
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1981
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2523
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16
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4766
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2883
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1861
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1454
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12323
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635
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1566
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8240
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2131
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Powered Laser Surgical Instrument
1349
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1168
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1133
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933
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818
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System, Imaging, Pulsed Doppler,...
793
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Prosthesis, Knee,...
787
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Hearing Aid, Air-conduction,...
740
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Laparoscope, General & Plastic...
706
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Implant, Endosseous, Root-form
675
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510k Database
Manufacturers
US
Antibodies, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Antibodies, Inc. - FDA 510(k) Cleared Devices
16 submissions
·
16 cleared
·
Since 1977
16
Total
16
Cleared
0
Denied
FDA 510(k) Regulatory Record - Antibodies, Inc.
Chemistry
✕
4
devices
1-4 of 4
Filters
Cleared
Nov 01, 1982
CORTISOL RIA KIT
K822892
·
CGR
Chemistry
·
34d
Cleared
Dec 19, 1980
AMIKACIN RIA KIT
K802877
·
KLQ
Chemistry
·
32d
Cleared
Sep 04, 1979
TSH RIA KIT
K791217
·
JLW
Chemistry
·
64d
Cleared
Sep 13, 1977
T3 UPTAKE DIAG. KIT
K771585
Chemistry
·
26d
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16
Immunology
8
Chemistry
4
Microbiology
2
Toxicology
2